Category: Health Law

Quality, transparency, patient advocacy- three themes in Dr. Marty Makary’s New York Times Bestseller- Unaccountable. With these three tenets that Dr. Makary has essentially devoted his career, and this book to, it is quite baffling to see how he missed the mark when he describes Ambulatory Surgery Centers (ASCs).

Transparency– Dr. Makary describes in shocking historic detail, how hard hospitals around the country work to keep quality reporting private. Further, he describes how hospitals tried to resist reporting quality at all. On the contrary, in 2006, the ASC community began advocating to the Centers for Medicare & Medicaid Services (CMS) to establish a uniform quality reporting system that would allow ASCs to publicly demonstrate their performance on quality measures. The ASC community together volunteered this information, and lobbied CMS to create the CMS the Ambulatory Surgical Center Quality Reporting (ASCQR) Program on October 1, 2012. This culture of transparency is what Dr. Makary seems to long for in his book. He praises the national registries and special societies that accurately measure patient outcomes in the hospital setting. Dr. Makary rightly believes that these measures create more accountability, and thus better outcomes for patients. However, in the hospital setting, these measures are not for the public. As Dr. Makary states, they are “locked and sealed” and considered “sensitive data.” As such, it’s confusing to see how Dr. Makary’s criticism of ASCs.

Quality– Mr. Makary repeatedly makes it seems as though ASCs are rouge facilities. He explicitly states that ASCs are less safe place to be and if it were him, he would choose an HOPD. Unfortunately, the patient’s choice of site of care isn’t that simple. The notion that ASCs are “less safe” compared to the HOPD setting is simply untrue. In fact, here is a graphic that shows the safety requirements between ASCs and HOPDs.

Currently, according to the Ambulatory Surgery Center Association, there are more than 5,400 Medicare-certified ASCs throughout the country that meet or exceed the health and safety standards set by the Centers for Medicare & Medicaid Services (CMS). These ASCs must also comply with an extensive set of infection prevention standards that are monitored internally at each ASC daily and evaluated by external inspectors.

In addition to the extensive requirements already in place by CMS, more than two-thirds of ASCs seek voluntary accreditation from one of four accrediting bodies: the Joint Commission, the American Association for Accreditation of Ambulatory Surgery Facilities, The Accreditation Association for Ambulatory Health Care, Healthcare Facilities Accreditation Program and the Institute for Medical Quality. This voluntary accreditation, and the majority of ASCs who participate in it, once again speaks to the ASC culture of quality and transparency.

Further, Dr. Makary’s comparison of being in an ASC like being in a “creek without a paddle is provocative and misleading. As stated in 42 CFR 416 and 482, ASCs are required to have a written hospital transfer agreement, and all physicians must have operating privileges within those hospitals, in the unlikely event a patient is transferred to a hospital from an ASC.

Patient Advocacy– Dr. Makary believes in a patient advocating for themselves and making informed choices on behalf of their care. The blind and natural decision would always default to going to a hospital, even for the most simple of procedures. However, do those simple procedures really need to be at a hospital- where the cost is incredibly higher, the stay is generally longer, and in some cases, a more dangerous setting? More and more studies show that healtheconomics and cost of care impacts at patient’s overall health. In today’s healthcare world it is unwise to not examine healthcare costs when designing a patient’s care. Naturally, because hospitals are massive facilities, with hundreds of employees, the overhead costs are greatly more than that of an ASC. This is one of the many reasons, Medicare pays 47% of what it pays to the hospital for the same exact procedure. As such, many informed patient advocate to have their procedures in the ASC. Whether the reason is because of the lower infection rates, the lower cost, or the ability to leave the same day, patients should discuss this with their doctors to determine what is best for them. Ideally, a doctor will review a patient’s comorbidities and the complexity of the procedure, taking a holistic approach and deciding. As such, blindly selecting the hospital every time is irresponsible advice from Dr. Makary.

Dr. Makary and ASCs celebrate many of the same ideals. It is where healthcare should be going. A safe, regulated, transparent site of care, that puts the patient first. It’s unfortunate Dr. Makary does not see that.

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By: Nawa Arsala Lodin
Last week, Essentia Health reportedly fired 50 employees who refused to get a flu shot. Essentia Health is a health system based in Minnesota, Wisconsin, North Dakota and Idaho, with 15 hospitals and 75 clinics. Essentia’s Chief Patient Safety Officer warned that staff that do not get the flu shot could lose their jobs. Additionally, staff with religious or medical reasons, were exempt from the requirement.

Requiring vaccinations in the school setting or in the healthcare setting are not novel. They are generally a condition of employment or attendance. Further, vaccination laws are not novel. In fact, the very first laws requiring the smallpox vaccination dates back to 1809. There are no federal requirements for vaccinations, as it is considered the police power of the state. All 50 states have some level of mandated vaccinations. While there are no federal requirements for vaccinations, the Center for Medicare and Medicaid Services does consider the number of healthcare staff with the vaccination a factor in its Inpatient Quality Reporting Program.

Further, the Center for Disease Control and Prevention recommends that all U.S. healthcare workers get vaccinated annually for the flu. The CDC itself does not mandate immunizations, but its recommendations are impactful and considered in decisions made by state legislature. Essentia’s chief patient safety officer and the American College of Physicians both believe that healthcare workers have an ethical obligation to vaccinate against the flu. However, an ethical obligation does not necessarily mean a legal obligation.

The constitutionality of mandating vaccinations has been solidified, so long as it is necessary, not discriminatory and not arbitrary. The two common exemptions considered persuasive by the courts are medical exemptions and religious exemptions. Both are widely accepted by schools, workplaces and the judiciary. The judiciary traditionally examines medical expertise in its review of mandatory immunizations. This analysis is how the courts determine if the vaccination, and not getting the vaccination and being terminated as arbitrary. In the case of the flu shot, the scientific evidence is undoubtedly sufficient to support a mandatory vaccination. Essentia is one of hundreds of healthcare systems that mandate the flu shot. Considering the common exceptions, the warning prior to termination and the clear scientific evidence to support the immunization, it is unlikely claims against Essentia will be successful.